VPHM - Sector: Healthcare---Industry: Biotechnology & Drugs

[la-onda]

ViroPharma Selected to Join NASDAQ Global Select Market
Monday June 26, 12:00 pm ET

EXTON, Pa., June 26 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM - News) today announced that it was selected for listing on the NASDAQ Global Select Market which is expected to be implemented by NASDAQ on July 3, 2006. Standards for initial inclusion in the NASDAQ Global Select Market will have financial and liquidity requirements that are higher than those of any other market in the world.

"I am extremely pleased to announce that ViroPharma has met the stringent standards for inclusion into the NASDAQ Global Select Market; we certainly feel this inclusion is demonstrative of our excellent financial position and view this as another significant positive development in ViroPharma's history," stated Michel de Rosen, ViroPharma's chief executive officer.

Effective on July 3rd, NASDAQ-listed companies will be classified under three listing tiers - NASDAQ Global Select Market, NASDAQ Global Market, and NASDAQ Capital Market. NASDAQ also plans to launch indexes based on these new tiers.

"ViroPharma is an example of an industry leader that has achieved superior listing standards, which clearly defines the essence of the NASDAQ Global Select Market," said Bruce Aust, Executive Vice President, NASDAQ's Corporate Client Group. "NASDAQ is focused on leading a race to the top in terms of listing qualifications. In recognizing these companies, we are highlighting their achievement in meeting the requirements to be included in the market with the highest listing standards in the world," added Mr. Aust.

NASDAQ announced the new three-tier listing classification in February 2006. All three market tiers will maintain rigorous listing and corporate governance standards. For additional information about the NASDAQ Global Select Market, please go to: http://www.nasdaq.com/GlobalSelect.

[la-onda]

short interest update:

[la-onda]

news out:
ViroPharma Announces Preclinical Data Supporting Utility of Non-Toxigenic Clostridium Difficile Against Epidemic Strain
Tuesday , June 27, 2006 10:31 ET

EXTON, Pa., June 27, 2006 /PRNewswire-FirstCall via COMTEX/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced the presentation of new data from preclinical studies of non-toxigenic Clostridium difficile at the 5th International Meeting on the Molecular Biology and Pathogenesis of Clostridia (ClostPath), held from June 21st through 25th in Nottingham, UK. These data showed NTCD to be protective against the currently circulating hypervirulent "BI" strain of C. difficile in a hamster model. Additional data presented during the meeting support the protection data by demonstrating that NTCD displays higher adherence to human mucosal cells compared to the BI strain and to traditional strains of C. difficile.

"These data are important, as they demonstrate that non-toxigenic C. difficile protects in an animal model against the dangerous hypervirulent strain of C. difficile that appears to be responsible for an epidemic of C. difficile-associated disease (CDAD) that is spreading throughout the U.S., Canada, and Europe," commented Colin Broom, M.D., ViroPharma's chief scientific officer. "These data are not only significant, but essential as current and future therapies would need to consider effectiveness against this hypervirulent strain, which is associated with a substantial increase in the severity of CDAD in humans."

"These new adherence data are particularly important since intestinal mucosal cell adhesion is a potential virulence factor of the BI strain," added Dale Gerding, M.D., associate chief of staff for research at the Hines VA Hospital. "The superior adherence of NTCD strain M3 compared to the hypervirulent BI strains also further corroborates the finding that it is highly protective in an animal model for CDAD against the BI strains. The high level of protection afforded by NTCD against this virulent epidemic strain in preclinical models of CDAD is encouraging for the development of this new therapeutic approach."

Protection data were described in an abstract entitled, "Non-Toxigenic Clostridium Difficile (CD) Protects Hamsters against Historic and Epidemic Toxigenic 'BI' Strains," by K.J. Nagaro et al. In this study, the efficacy of NTCD in preventing disease in hamsters challenged with toxigenic BI strains was assessed. Animals were orally inoculated with one of two strains of NTCD (REA types M3 and T7) and then challenged with either a historic BI strain (BI1) or the BI strain causing the current epidemic (BI6), both of which have been previously shown to be 100% fatal in this model. Inoculation with M3 prevented fatal CDAD in 9 out of 10 hamsters challenged with BI6 (p<0.0003) and 10 of 10 challenged with BI1 (p<0.00005). Inoculation with T7 prevented fatal disease in 5 of 10 hamsters challenged with BI6 (p<0.02), and 10 of 10 challenged with BI1 (p<0.00005). The authors concluded that colonization with NTCD, particularly type M3, is highly effective in preventing CDAD in hamsters caused by REA group BI strains, and provides a novel approach with the potential to prevent CDAD caused by the new epidemic strains in humans.

The adherence data were described in an abstract entitled, "Hypervirulent Epidemic Strains Of Clostridium Difficile Have Altered Host Cell Adherence And Protein Expression," by G. Vedantam et al. This study tested the hypothesis that increased adherence of the epidemic BI strain to mucosal lining contributes to the enhanced virulence of this strain. The results showed that an NTCD strain, REA type M3, displayed the highest adherence to Caco-2 human intestinal epithelial cells (a cell line that when grown in cell culture differentiates and assumes properties of intestinal mucosa cells), followed by BI strains including the circulating hypervirulent strains (BI6, BI8 and BI17). Toxigenic, non-epidemic strains showed the lowest adherence. Epidemic strains have enhanced adherence to human epithelial cells which is associated with an increased expression of surface layer proteins which may allow them to predominate in their environment and cause more severe disease outcomes that are not solely toxin-related. The high level of adherence demonstrated by the NTCD M3 strain corroborates the high levels of protection observed against BI strain challenge in the hamster model.

ViroPharma entered into a licensing agreement in February of 2006 with Dr. Gerding for the rights to develop non-toxigenic strains of C. difficile, including the M3 strain, for the treatment and prevention of CDAD. ViroPharma plans to initially focus its efforts on the opportunity to prevent recurrence of CDAD following treatment with Vancocin.

[la-onda]

IMS Health May 2006 Sales[/color]
by: irc203
Long-Term Sentiment: Strong Buy    06/29/06 09:37 am
Msg: 137062 of 137290

Monthly sales from wholesalers to pharmacies for the month of May totaled $15,676,630, another new record for average weekly sales. April sales totaled $15,482,228. We have 2 very strong monthly sales numbers. It appears that the 2nd quarter is going to establish a new record Vancocin sales for VPHM.

Is the chart a bullish three inside up candle pattern ??

[calven]

VPHM suddenly starting to look a little better to me...not a buyer yet but I am finally watching it for a possible entry. I like the mystery volume today...

[Lucas Scott]

Volume not a mystery. VPHM added to the Russell 3000 index. The index is reconstituted once a year. You can see similar volume spikes on other stocks that got added, like BAMM, DVW, LDSH for example.

Here is the preliminary list of additions:

http://www.russell.com/US/Indexes/US/Reconstitution/recon_additions.asp

[la-onda]

fyi:
ViroPharma Submits Scientific Arguments in Supplement to Vancocin Petition for Stay of Action
Friday , June 30, 2006 18:21 ET

EXTON, Pa., June 30, 2006 /PRNewswire-FirstCall via COMTEX/ -- ViroPharma Incorporated (Nasdaq: VPHM) today submitted a supplement to its Petition for Stay of Action with the FDA regarding the bioequivalence requirements for abbreviated new drug applications (ANDAs) that seek to copy Vancocin capsules. The document sets forth scientific arguments supporting ViroPharma's strong belief that the decision of the FDA's Office of Generic Drugs (OGD) to modify the bioequivalence standards for generic copies of Vancocin capsules is scientifically flawed.

The submission made by ViroPharma will be available in its entirety later today on ViroPharma's corporate website, at http://www.viropharma.com/OGDpetition. The document will also be furnished with the SEC as an exhibit to a Current Report on Form 8-K, and will be available on the EDGAR section of the SEC website as well as the SEC filings page of the 'investing' section of the ViroPharma website. The company also expects that the document will become available on the docket management section of the FDA website within approximately two weeks.

The Company believes that its latest submission demonstrates that the OGD's proposal for demonstrating bioequivalence of a generic version of Vancocin capsules using only in vitro dissolution testing instead of human clinical trials is not justifiable, and presents an unacceptably high risk of approving a bioinequivalent product. Because Vancocin treats two potentially life-threatening diseases, Clostridium difficile-associated disease (CDAD) and enterocolitis caused by Staphylococcus aureus, anything less than an in vivo demonstration of bioequivalence in those with CDAD may expose patients to unnecessary risk and raise significant clinical and public health concerns.

Previously, on May 31, 2006, ViroPharma filed a supplement describing its strong belief that the OGD's decision to lower the bioequivalence standards for generic copies of Vancocin violated numerous federal statutes in addition to the FDA's own regulations with the result that the new standard cannot, as a matter of law, be used in the review or approval of applications for generic versions of Vancocin.

ViroPharma intends to continue to vigorously oppose any approach that does not require rigorous scientific methods including human clinical studies, consistent with good medicine and science. The company also believes that, given the growing number of patients with severe, and possibly life-threatening, CDAD, the appropriate expert advisory groups must validate the scientific and medical appropriateness of the approval standards for a generic locally acting vancomycin capsule product.

C. difficile is a bacterium, which under certain circumstances, typically after antibiotic therapy, can colonize the lower gastrointestinal tract where it may produce toxins which cause inflammation of the colon and diarrhea, and the associated complications of disease, including death. Advanced age, gastrointestinal surgery/manipulation, long length of stay in healthcare settings, a serious underlying illness and compromised immunity are conditions associated with increased risk of disease. According to the CDC, there are approximately 3,000,000 cases of antibiotic-associated diarrhea per year, of which 15 to 25 percent are caused by C. difficile.

[la-onda]

ViroPharma wants to stop FDA from easing generics rules
Monday , July 03, 2006 16:17 ET

By Linda Loyd

Jul 03, 2006 (The Philadelphia Inquirer - Knight Ridder/Tribune Business News via COMTEX) -- ViroPharma Inc. said today it has submitted a supplement to its petition to try to stop the U.S. Food and Drug Administration from allowing lower-cost generic copies to be made of its antibiotic Vancocin based solely on laboratory studies.

The Exton company, in a filing with the Securities and Exchange Commission, said it believes that the FDA's proposal for evaluating generic drugs using only laboratory testing instead of human clinical trials should not be applicable to Vancocin capsules, and presents an "unacceptably high risk" of approving a product that is not bioequivalent.

ViroPharma filed a petition to stay the FDA's action in March, and now has filed a supplement document to oppose the change, calling it "scientifically flawed."

Vancocin is ViroPharma's biggest revenue source and accounted for $125.9 million of the company's $132.4 million in revenue in 2005.

ViroPharma shares fell 33 percent in March on investor concern that Vancocin could face generic competition sooner than expected. Investors had assumed Vancocin sales would be protected until 2010. Shares were unchanged at $8.62 in early afternoon trading.

The company said the FDA's Office of Generic Drugs has changed its approach and may waive a requirement that generic-drug makers conduct clinical trials to establish "bioequivalence" for certain gastrointestinal drugs like Vancocin. Doing so would allow firms to perform simpler tests that could speed lower-cost generic versions to market.

ViroPharma bought Vancocin from Eli Lilly & Co. in 2004, and has projected continued sales growth because Vancocin is the key treatment for Clostridium difficile, a sometimes-deadly bacterium that has recently become more virulent and widespread.

[la-onda]

 Biotechs: Cowen Likes Fundamentals, Favors Large Caps
Friday , July 07, 2006 09:30 ET

Cowen & Co. expects the "earnings-driven" firms in their coverage will post strong Q2 results. For the industry Cowen notes "strong fundamentals make a prolonged downturn unlikely." The firm sees "full pipelines, good earnings growth and visibility, multiple new product launches, and continued pricing power." Cowen favors large caps, specifically AMGN, BIIB, CEPH, GENZ, and GILD. Select mid- and small cap recommendations include ALTH, ALXN, BMRN, CRXX, ENCY, KERX, ONXX, PANC, and VRTX. Cowen says avoid AMLN, IDIX, and IMCL.

+ AMGN, BIIB, CEPH, DNA, GILD, ILMN and VPHM: Cowen says these are their favorites to beat the consensus in Q2.

-- GENZ, ICOS, IMCL, MEDI and UTHR: Cowen sees these names producing Q2 results that are at least in line.

(-) CIPH, CVTX, NTMD, and TRCA: Cowen advises caution on these names due to Q2 expectations.

http://www.knobias.com/individual/public/news.htm?eid=3.1.601a392ff1b97f4d35552985973ecfd25c20771b0aa9ab7d689b68e965792cf6

[la-onda]

yahoo board quotation:
Crunching data from mid june CCs[/color][/b]
by: satrasal
Long-Term Sentiment: Strong Buy    07/11/06 07:22 am
Msg: 138556 of 138558

Scrip growth:
Scrip growth (first 5 months 2006 over first 5 2005 = 30%
May 06 monthly sequential scrip growth over april 2006 = 10% surge in scrips.

CDAD progression data:
CDC reports greater cdad incidence of 20% spread to new populations. CDAD identified now in 20 states (priorly 12) A new strain has emerged killing patients in 4 days as opposed to 3 weeks.
Alternatives: decreasing effectiveness of competitor metronidazol to 62% efficacy from 85% efficacy.

Revs:
q1 05 21 mil
q2 05 29 mil
q3 05 36 mil
q4 05 40 mil

q1 06 29 mil


Price increases in 2005 were 17% in dec 04, 26% in March 05, 22% in Aug 05 cumulatively 80% over 2004.
Succesive increases led to continuous wholesaler overstocking.
The Aug wholesaler price increase $446 (20 capsules) from $368 should have taken q4 revs to more than 43 mil from the q3 36 mil if wholesalers were using just-in-time inventory.
VPHM only hit 40 mil in Q4. Obviously wholesalers had been stockpiling. Presumably they started stockpiling in q1 05 after the dec 04 price increase as they anticipated the march05 second price increase.

The question is how much was stockpiled throughout 2005 and how much is left in the pipeline given 2006 Jan-May scrip growth of 30% over 2005.

2004 revs were 54 mil, 2005 revs 126 mil
At 2005 yoy scrip growth of 35% and flat pricing we should have 2005 revs of 73 mil.
We have 53 mil in 2005 from pricing increases and stockpiles.
If we factor in the price increases we get roughly 110 mil 2005 revs. This suggests we had 16 mil excess inventory- possibly 6 weeks of overhang at 2005 demand levels.

Now given the 2006 scrip growth of 30% (comparing jan to may for 2005 and 2006), no reason to stockpile and the sudden monthly 10% surge in scrips in May 2006.... what do you think revs should be for Q1 2006 and q2 2006.

If we take Q1 2005 (21 mil) and wash out the first 17% price increase we get 18 mil. We can assume this is at zero growth. Factor in all 3 price increases and we should have Q1 2006 at 32 mil. (actual number was 29 mil) Factor in 30% scrip growth and we have 42 mil. So a minimum 13 mil overhang got worked off on Q1. There was a 3 mil overhang going into Q2.

Q2 2006 has to be 39 mil revs at a minimum.
Analsyt projections are 42 mil.
Given the May scrips spike and the 3 mil overhang we will likely exceed it.

(Side note: In Nov 2005 analysts were projecting another 25% price increase. It didnt happen and hasn't happened. Instead VPHM price moved from 24 to 16 in Nov 2005 and into the dec 12 10 mil offering at $16.75. Money moved back in after dec but not convincingly. VpHm was in distribution after a yearlong stockpile. We churned from Nov05 to March06 when the OGD news hit.)

Margins:
Margins are down to 80% due to an extra payment to Lilly of approx 2.2 mil per q to ensure increased supply of Vanc.
However, new supply chain costs (with alibaba/ofg) reduce cost of sales to 50% of current costs.
So while short term margins are at 80%, margins for full year 2006 will be much hihger. You do the math. Product costs were 13%, short term Lilly extra cost took it to 19%, and they expect long term product costs to drop to 7%. Margins in q406 will be 93% since Lilly is only manufacturing thru sept 2006.
Also, VPHM has already begun to use product from Alibaba/OFG in q2 itself- perhaps Alibaba came online earlier than anticipated; and/or Lilly is sold out despite the extra supply contracted for.

OGD submissions:
Apart from the fact that OGD violated multiple laws, it specifically violated guidelines designating vancocin-like compunds as excluded from bio-equivalent generics.

Current position:
No debt, 156 mil cash, 176 mil working capital, cash flow positive for last 5 Qs, tax rate of approx 39% for 2006 (0% for 2005)

[la-onda]

ViroPharma to Discuss Scientific Supplement to Petition for Stay of Action Regarding Generic Vancocin on July 13, 2006
Wednesday, July 12, 2006 15:01 ET

EXTON, Pa., July 12, 2006 /PRNewswire-FirstCall via COMTEX/ -- ViroPharma Incorporated (Nasdaq: VPHM) will host a conference call and live audio webcast at 9:00 a.m. Eastern Time on Thursday, July 13th to discuss the recent scientific supplement to their pending petition for Stay of Action with the FDA regarding the bioequivalence requirements for abbreviated new drug applications (ANDAs) that seek to copy Vancocin capsules.

The live webcast of the conference call will be accessible via ViroPharma's corporate website at http://www.viropharma.com. An audio archive will be available at the same address until July 28, 2006. To participate in the conference call, please dial (800) 391-2548 (domestic) and (302) 709-8328 (international). After placing the call, please tell the operator you wish to join the ViroPharma investor conference call.

&

Piper Jaffray & Co. - What do They Know
by: Dow18K
Long-Term Sentiment: Strong Buy    07/12/06 10:44 pm
Msg: 138901 of 138939

VPHM :VPHM Posts Its Scientific Arguments To FDA
2006-07-05 02:46 (New York)
Piper Jaffray & Co.
Hot Comment
July 5, 2006
ViroPharma Incorporated (VPHM - $8.66)
Market Perform Volatility: High
Health Care
VPHM Posts Its Scientific Arguments To FDA

Thomas Wei, Senior Research Analyst
212 284-9305, [email protected]
Gur A. Roshwalb, M.D., Research Analyst
212-284-9314, [email protected]

KEY POINTS:
Intriguing scientific arguments made by VPHM, but Vancocin generic uncertainty
still remains a near-term overhang.

* VPHM's Scientific Arguments Challenges Dissolution Testing For Vancocin
Generic. VPHM published its scientific supplement to its stay of action
regarding the recent opinion from the Office of Generic Drugs (OGD) to allow
simple dissolution testing for the approval of a generic Vancocin in lieu of
full scale clinical trials. While VPHM outlines several arguments, we
believe that the company's strongest argument is its attack against the
assumption that Vancocin is rapidly dissolving.

* Attacking The Assumption Of Rapid Dissolution - Two Part Argument. The core
premise of waiving full scale clinical trials for a generic is that the drug
in question needs to be rapidly dissolving, which the FDA defines as 85%
dissolved under three different pH settings within 30 minutes. VPHM revealed
for the first time the actual data for Vancocin dissolution at the three
different pH setting required under the waiver for bioequivalence. We were
surprised to learn that Vancocin may not be rapidly dissolving under all
conditions required by the FDA and are now perplexed how the FDA arrived at
its conclusion that Vancocin was eligible for a clinical trial waiver.
Second, VPHM notes that the dissolution methodology suggested is meant for
healthy individuals and points out that patients infected with C. difficile-
associated disease (CDAD) have both different intestinal pHs, some out of
the range suggested for dissolution testing by the FDA, and also potentially
accelerated different gastric emptying and transit rates relative to a
healthy adult (i.e. the 30 minutes used in dissolution testing at a given pH
may be too long to apply to patients with hypermotility due to CDAD). The
company points to anecdotal evidence that patients with CDAD have found
incompletely dissolved pills in stool samples. While we believe that this is
potentially a valid argument, we note that a quick literature search did not
reveal any comprehensive studies on the rate of gastric emptying or transit
in CDAD patients, and as such, the company may need to generate data to
support its argument that the residence time of Vancocin in the stomach is
too short or too variable to allow for the dissolution study approach. We
also remain uncertain how the FDA will view the fact that the target of drug
activity is the colon, which would allow time for transit and dissolution
through both the stomach and the small intestine.

* Lack Of Insight Into OGD Decision Make Analysis Difficult. It remains
difficult to determine how the FDA will receive these arguments, as the
basis for the change in stance by OGD is still unknown. We believe a
response from the FDA on VPHM's petition could occur as early as year-end
2006. If VPHM is unsuccessful in its arguments, it may be possible for
generics to enter the market as early as 2008.

PRICE TARGET AND JUSTIFICATION:
Our current $12 price target is based on sum-of-the-parts analysis: $6 for
Vancocin + $2 for cash + $3.50 for pipeline.

RISKS TO ACHIEVEMENT OF TARGET PRICE:
Risks include but are not limited to: 1) Vancocin competition, and 2) failures
in maribavir and/or HCV programs.

[la-onda]

Zacks Bull and Bear of the Day Highlights: ViroPharma, Energy Conversion Devices, D.R. Horton and First Data Corp.
Friday , July 14, 2006 06:00 ET

CHICAGO, Jul 14, 2006 (BUSINESS WIRE) -- Zacks Equity Research highlights ViroPharma, Inc. (Nasdaq:VPHM) as the Bull of the Day and Energy Conversion Devices (Nasdaq:ENER) as the Bear of the Day. In addition, Zacks Equity Research provides analysis on D.R. Horton (NYSE:DHI) and First Data Corp. (NYSE:FDC). Full analysis of all four stocks is available at http://at.zacks.com/?id=2676.

Here is a synopsis of all four stocks:

Bull of the Day:

Our Bull of the Day recommendation is for ViroPharma, Inc. (Nasdaq:VPHM), a pharmaceutical company engaged in the development and commercialization of products that address diseases caused by infectious agents such as a virus or pathogenic bacteria. The company has one approved product, Vancocin Capsules, for the treatment of antibiotic-associated infection, and two mid-stage candidates for viral infections. Recent concerns over a generic alternative to Vancocin and poor inventory management have hampered the stock. Although the above two issues will continue to linger, ViroPharma is trading at a significant discount to its peers. Our target is $16.

DOWNLOAD the 9 slides:
http://www.zacks.com/newsroom/commentary/index_pdf.php?id=3290

[la-onda]

ViroPharma "buy"

Friday, July 14, 2006 11:06:18 AM ET
Lazard Capital

NEW YORK, July 14 (newratings.com) - Analysts at Lazard Capital maintain their "buy" rating on ViroPharma Incorporated (ticker: VPHM).
The target price is set to $21.
http://www.newratings.com/analyst_news/article_1319257.html

[la-onda]

Final washout today IMO

ViroPharma downgraded to "underperform"

Tuesday, July 18, 2006 10:41:24 AM ET
Infinium Securities

NEW YORK, July 18 (newratings.com) - Analysts at Infinium Securities downgrade ViroPharma Incorporated (ticker: VPHM) from "outperform" to "underperform." The target price has been reduced from $11 to $6.5.


VPHM seems no to recover, was Infinium the short player?
30 minutes after VPHM has published their earings date ?
Just a few days ago after the 16$ and 21 $ rating?
Just read the ZAck report I have posted earlier 

nachtigall ick hör dir trapsen


cheers
Oliver

[basonista]

Final washout today IMO

Those are my thoughts also, Oliver.  I'm back in at 7.31.  Nice recovery on higher volume.  Let's see this close in the green to add some validity to our case.    Good luck!